Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars

A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment. This article discusses strategies for the development, optimization, and validation of NAb assays in relation to biosimilar and originator therapeutics.

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